Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000576022
Ethics application status
Approved
Date submitted
15/07/2010
Date registered
16/07/2010
Date last updated
23/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison on the effectiveness of a novel intervention programme against a traditional supervised exercise programme in improving the fall efficacy in the moderate frail population aged 60 and above
Scientific title
A comparison on the effectiveness of the Nintendo Wii Active programme against a supervised exercise programme in improving the fall efficacy in the moderate frail population aged 60 and above
Secondary ID [1] 252236 0
Singhealth services foundation research grant SHF/FG397S/2009
Universal Trial Number (UTN)
U1111-1116-0226
Trial acronym
Evaluating Frail Fall Efficacy by Comparison of Treatments (EFFECT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall efficacy 257748 0
Agility 257749 0
Balance 257750 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257926 257926 0 0
Physiotherapy
Musculoskeletal 257931 257931 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Wii Active exercise programme 1-2x/week . 1 session approximately an hour (rest time inclusive).
Concurrently, home exercise 2x/week on non-programme days. Each session between 0.5-1 hour.
Sessions are in small groups supervised by a physiotherapist over a period of 12 weeks.
Wii intervention 20 minutes, stretching 5 minutes, balance training 10 minutes, strength training 10 minutes, 10 minutes variable training based on subject needs.
Home programme: Stretching, balance and agility training, strength training and cardiovascular training.
Intervention code [1] 256814 0
Rehabilitation
Intervention code [2] 256815 0
Prevention
Comparator / control treatment
Traditional exercise programme involving aerobic, balance and strength training 1-2x/week. 1 session approximately an hour (rest time inclusive)
Concurrently, home exercise 2x/week on non-programme days. Each session between 0.5-1 hour.
Sessions are in small groups supervised by a physiotherapist over a period of 12 weeks.
Cardiovascular training 15 minutes, stretching 5 minutes, balance training 10 minutes, strength training 10 minutes, 10 minutes variable training based on subject needs.
Home programme: Stretching, balance and agility training, strength training and cardiovascular training.
Control group
Active

Outcomes
Primary outcome [1] 258787 0
Modified fall efficacy scale (MFES)
Timepoint [1] 258787 0
Baseline, 13th week and 24th week
Primary outcome [2] 258788 0
Timed up and go (TUG)
Timepoint [2] 258788 0
Baseline, 13th week and 24th week
Primary outcome [3] 258789 0
6 minutes walk test
Timepoint [3] 258789 0
Baseline, 13th week and 24th week
Secondary outcome [1] 264851 0
None
Timepoint [1] 264851 0
None
Secondary outcome [2] 264852 0
Narrow corridor walk
Timepoint [2] 264852 0
Baseline, 13th week
Secondary outcome [3] 264853 0
4 square step test
Timepoint [3] 264853 0
Baseline, 13th week
Secondary outcome [4] 264854 0
Physiological profile approach (PPA)
Timepoint [4] 264854 0
Baseline, 13th week and 24th week

Eligibility
Key inclusion criteria
Community dwelling
Poor fall efficacy
Moderately frail (short physical performance battery score 5-9)
Ambulatory independent (assistive devices accepted: walking stick and quad-stick)
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Permanent bed-bound
Disabled in ambulation / requires a walking frame or rollator frame for ambulation
Significant cognitive disorder
Untreated aortic stenosis or ischemia
Unrepaired aortic, cerebral or abdominal aneurysm
End-stage illness or disease
Life expectancy less than a year
Cerebral haemorrhage within the past 3 months
Fractures in healing phase
Surgery within the past 6 months
Pulmonary embolism or deep vein thrombosis (DVT) within 3 months
Uncontrolled medical condition(s)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Additional 12 weeks of home exercises post intervention to assess carried over effect of compliance
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/06/2010
Actual
30/06/2010
Date of last participant enrolment
Anticipated
Actual
10/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 2768 0
Singapore
State/province [1] 2768 0

Funding & Sponsors
Funding source category [1] 257290 0
Hospital
Name [1] 257290 0
Singhealth Foundation
Country [1] 257290 0
Singapore
Primary sponsor type
Individual
Name
Kwok Boon Chong
Address
Block 3 Level 1 Rehabilitation Centre Physiotherapy Singapore General Hospital Outram Road S(169608)
Country
Singapore
Secondary sponsor category [1] 256535 0
Hospital
Name [1] 256535 0
Rehabilitation Centre Physiotherapy
Address [1] 256535 0
Block 3 Level 1 Rehabilitation Centre Physiotherapy Singapore General Hospital Outram Road S(169608)
Country [1] 256535 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259315 0
Institutional Review Board
Ethics committee address [1] 259315 0
Ethics committee country [1] 259315 0
Singapore
Date submitted for ethics approval [1] 259315 0
Approval date [1] 259315 0
19/05/2010
Ethics approval number [1] 259315 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31399 0
Mr Kwok Boon Chong
Address 31399 0
3 Fusionpolis Link, Nexus@one-north, #05-10 S(138543)
Country 31399 0
Singapore
Phone 31399 0
+65 68962289
Fax 31399 0
Email 31399 0
[email protected]
Contact person for public queries
Name 14646 0
Kwok Boon Chong
Address 14646 0
3 Fusionpolis Link, Nexus@one-north, #05-10 S(138543)
Country 14646 0
Singapore
Phone 14646 0
+65 68962289
Fax 14646 0
Email 14646 0
[email protected]
Contact person for scientific queries
Name 5574 0
Kwok Boon Chong
Address 5574 0
3 Fusionpolis Link, Nexus@one-north, #05-10 S(138543)
Country 5574 0
Singapore
Phone 5574 0
+65 68962289
Fax 5574 0
Email 5574 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of the Frails' Fall Efficacy by Comparing Treatments (EFFECT) on reducing fall and fear of fall in moderately frail older adults: Study protocol for a randomised control trial.2011https://dx.doi.org/10.1186/1745-6215-12-155
Dimensions AIThe minimal clinically important difference of six-minute walk in Asian older adults2013https://doi.org/10.1186/1471-2318-13-23
N.B. These documents automatically identified may not have been verified by the study sponsor.